AssayIndex

MKM-2508-P3929

Liraglutide · 10 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · manufactured 29 Aug 2025

CHARACTERISED
Lot code
MKM-2508-P3929
Supplier
MKM — Xi'an Mokemei Biotechnology Co., Ltd.
Compound
Liraglutide
Compound class
Incretin analogues and co-agonists
Declared label claim
10mg
Manufacture date
29 Aug 2025
Index quarter
2025-Q3
Independent assays
10
Laboratories involved
VendorInvestigate, Janoshik, Medutest, PeptideMeter
Provenance mix
Buyer-sourced ×1 · Supplier-supplied ×9
Section 1

Reproducibility across independent tests

Every report below is an observation of the same physical material. What they disagree about is measurement; what they agree about is the lot. The size of the disagreement is compared against what the contributing laboratories' own repeatability figures predict.

Independent assays 10
Median purity 98.21% n=10
Spread (max − min) 1.31pp n=10
Standard deviation 0.400pp n=10
96.296.897.598.298.999.5100.2This lot (MKM-2508-P3929)This lot (MKM-2508-P3929): Q1 97.99, median 98.20, Q3 98.55, n=10n=10All LiraglutideAll Liraglutide: Q1 98.45, median 99.02, Q3 99.53, n=154outlier 96.45outlier 96.59outlier 96.70outlier 96.74outlier 96.78outlier 96.78n=154 Purity (% area)
Figure 1. This lot's independent purity results against the whole Liraglutide record set in the index. The vertical line is the index acceptance specification for the incretin analogues and co-agonists class, 97.5 % area. A narrow box on the top row against a wide box on the bottom row is the ideal reading: it means the disagreement between lots is much larger than the disagreement within this one.
Section 2

Member reports 10

Every report the index holds on this lot. Each is a page carrying its own chromatogram, mass spectrum, mass balance, provenance and caveats.

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020353MKM-2508-P3929VendorInvestigate2025-Q397.546.62—Buyer-sourced1MARGINAL
AX-2025-020354MKM-2508-P3929Janoshik2025-Q397.966.0890.0Supplier-supplied0PASS
AX-2025-020355MKM-2508-P3929Medutest2025-Q398.856.89—Supplier-supplied0PASS
AX-2025-020356MKM-2508-P3929PeptideMeter2025-Q398.086.66103.5Supplier-supplied0PASS
AX-2025-020357MKM-2508-P3929Medutest2025-Q398.586.30—Supplier-supplied0FAIL
AX-2025-020358MKM-2508-P3929Medutest2025-Q398.556.63—Supplier-supplied1FAIL
AX-2025-020359MKM-2508-P3929Medutest2025-Q397.847.40—Supplier-supplied1FAIL
AX-2025-020360MKM-2508-P3929Janoshik2025-Q398.257.39—Supplier-supplied0PASS
AX-2025-020361MKM-2508-P3929Janoshik2025-Q398.556.99103.4Supplier-supplied1MARGINAL
AX-2025-020362MKM-2508-P3929Janoshik2025-Q398.167.03101.8Supplier-supplied0PASS
Section 3

By laboratory

Where more than one laboratory assayed this lot, the difference between them is a paired observation of their relative bias — the same material, the same time window, different instruments. Those pairs are what the index's bias estimates are built from.

LaboratoryReportsPurity results (% area)MedianGradientPublished bias (pp)Bias-adjusted
VendorInvestigate197.5497.5432min-0.1197.65
Janoshik497.96, 98.25, 98.55, 98.1698.2030min+0.0098.20
Medutest498.85, 98.58, 98.55, 97.8498.5625min+0.0898.48
PeptideMeter198.0898.0828min-0.0598.13

This lot contributes 6 paired comparisons to the inter-lab analysis.

Section 4

The supplier's certificate for this lot

One number the supplier wrote, beside the median of the numbers other people measured on the same physical material. That comparison is only available because the index groups by lot.

FigureSupplier COAThis reportIndex note
Purity (% area)98.3097.54divergence +0.09 pp vs batch median
Total impurities (% area)1.702.46
Largest single impurity (% area)not stated1.77
Water (%)6.36.62
Counter-ion (%)5.57.32
Peptide content (%w/w)87.6not determined
Endotoxin (EU/mg)0.170.45
Method stated on certificateYES—column, gradient and wavelength given
Section 5

Impurity fingerprint

The named impurities reported across this lot's assays, with how consistently each was seen. A fingerprint is what allows two lot numbers held by different companies to be identified as one bulk.

Named impurityReported inMedian % areaRange
deamidated (Asn→Asp, +1 Da)10 / 101.040.73–1.77
palmitoyl bis-adduct (+238 Da)10 / 100.440.27–0.56
des-palmitoyl liraglutide (−238 Da)10 / 100.130.07–0.20
γ-Glu regioisomer10 / 100.050.02–0.07
liraglutide dimer10 / 100.020.01–0.03
des-His1 truncate (−137 Da)9 / 100.030.01–0.04
Section 7

What this rollup does not establish